"Potential drug treatments are tested on paper, in laboratories and eventually in thousands of people. But every drug that goes through this cycle â€“ every drug that FDA approves â€“ carries some risk. One of the first lines of defense against "...
Anaphylaxis, Hypersensitivity and Immune-Mediated Reactions
Advise the patients and caregivers that reactions related to administration and infusion may occur during and after alglucosidase alfa treatment, including life-threatening anaphylaxis, hypersensitivity reactions, and immune-mediated reactions. Patients who have experienced anaphylaxis or hypersensitivity reactions may require close observation during and after alglucosidase alfa administration. Inform patients of the signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune-mediated reactions and have them seek medical care should signs and symptoms occur.
Risk of Acute Cardiorespiratory Failure
Advise patients and caregivers that patients with underlying respiratory illness or compromised cardiac or respiratory function may be at risk of acute cardiorespiratory failure. Patients with compromised cardiac or respiratory function may require close observation during and after alglucosidase alfa administration.
Inform patients and their caregivers that the Pompe Registry has been established in order to better understand the variability and progression of Pompe disease, and to continue to monitor and evaluate long-term treatment effects of alglucosidase alfa. The Pompe Registry will also monitor the effect of alglucosidase alfa on pregnant women and their offspring [see Use in Specific Populations]. Patients and their caregivers should be encouraged to participate in the Pompe Registry and advised that their participation is voluntary and may involve long-term follow-up. For more information regarding the registry program, visit www.pomperegistry.com or call 1-800-7454447.
Last reviewed on RxList: 8/18/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Lumizyme Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.